Calcium Resonium

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Calcium polystyrene sulfonate 99.93% (Binding capacity 1.7mEq/g);  ;  

Διαθέσιμο από:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Διεθνής Όνομα):

Calcium polystyrene sulfonate 99.93% (Binding capacity 1.7mEq/g)

Δοσολογία:

1.7 mEq/g

Φαρμακοτεχνική μορφή:

Powder for oral solution

Σύνθεση:

Active: Calcium polystyrene sulfonate 99.93% (Binding capacity 1.7mEq/g)     Excipient: Saccharin Vanillin

Μονάδες σε πακέτο:

Bottle, plastic, 1x300g, 300 g

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Purolite SA

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Bottle, plastic, 1x300g - 300 g - 36 months from date of manufacture stored at or below 30°C

Ημερομηνία της άδειας:

1979-04-26

Φύλλο οδηγιών χρήσης

Calcium Resonium®
1
CALCIUM RESONIUM®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CALCIUM RESONIUM?
Calcium Resonium contains the active ingredient calcium polystyrene
sulfonate. Calcium Resonium is used to help remove
excessive amounts of potassium from the blood. For more information,
see Section 1. Why am I using Calcium Resonium?
in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CALCIUM RESONIUM?
Do not use if you have ever had an allergic reaction to Calcium
Resonium or any of the ingredients listed at the end of the CMI,
have a bowel obstruction, have high calcium levels in the blood, have
high levels of parathyroid hormone, have multiple myeloma
(a cancer of the blood) or sarcoidosis, or have low levels of
potassium. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information,
see Section 2. What should I know before I use Calcium Resonium?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Calcium Resonium and affect how it
works. A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE CALCIUM RESONIUM?
•
Calcium Resonium can be given by mouth or rectally (via the back
passage).
•
The usual oral doses are 15 g three to four times daily for adults,
and 1 g/kg of body weight in divided doses for children. Do
not take Calcium Resonium with fruit juices or sorbitol. Take Calcium
Resonium at least 3 hours before or 3 hours after other
oral medications.
•
The usual rectal doses are 30 g in 150 mL of water or 10% dextrose in
water, as a retention enema for adults, with lower
dosages usually used for infants and children. For newborn babies, the
minimum effective dose range 0.5 g/kg to 1 g/kg
should be used.
More instructions can be found in Section 4

Αρχείο Π.Χ.Π.

calcium-resonium-ccdsv7-dsv8-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Calcium Resonium powder 1.7 mEq/g.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Resonium contains 99.93% calcium polystyrene sulfonate ground
and flavoured to a buff
coloured fine powder with a vanilla odour and sweet taste. The sodium
content of Calcium
Resonium is less than 1 mg/g. Calcium content is about 8% w/w (1.6-2.4
mmol/g).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder 300g.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Calcium Resonium is an ion-exchange resin. It is recommended for the
treatment of
hyperkalaemia associated with anuria and severe oliguria.
It is also used to treat hyperkalaemia in patients requiring dialysis
and in patients on regular
haemodialysis or on prolonged peritoneal dialysis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Calcium Resonium is for oral or rectal administration only. The dosage
recommendations
detailed below are a guide only; the precise requirements should be
determined on the basis of
regular clinical and serum electrolyte monitoring.
calcium-resonium-ccdsv7-dsv8-20jun22
Page 2
_ADULTS, INCLUDING THE ELDERLY _
Oral
Usual dose 15 g three or four times a day. The resin is given by mouth
as a suspension in a small
amount of water (3-4 mL per gram of resin), or it may be mixed with
some sweetened vehicle (but
not fruit juices, which contain potassium).
Administer at least 3 hours before or 3 hours after other oral
medications. For patients with
gastroparesis, a 6-hour separation should be considered (see Section
4.4 and Section 4.5).
Rectal
In cases where vomiting or upper gastrointestinal problems, including
paralytic ileus, may make
oral administration difficult, the resin may be given rectally in a
suspension of 30 g resin in 150
mL water or 10% dextrose in water, given as a daily retention enema.
In the initial stages,
administration by this route as well as orally may help to achieve a
more rapid lowering of the
serum potassium